Recall Z-1686-2016 ยท LSE Epstein-Barr Virus, Other
Diamedix Corporation
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
| Date | Oct 20, 2014 |
| Status | Terminated |
| Reason | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technica |
| Quantity | 588 kits |
| Distribution | Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981812 | EBV-VCA IGG ELISA TEST SYSTEM Diamedix Corp., Mar 4, 1999 |